Abstract: TH-PO135
Impact of Upacicalcet on Bone Metabolism in Patients on Hemodialysis Who Have Secondary Hyperparathyroidism: Post Hoc Analysis Based on Baseline Alkaline Phosphatase
Session Information
- CKD-MBD: Clinical
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 502 Bone and Mineral Metabolism: Clinical
Authors
- Yamamoto, Suguru, Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
- Yoneda, Shinji, Medical Affairs Department, Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan
- Kazama, Junichiro James, Division of Nephrology and Hypertension, Fukushima Medical University, Fukushima, Japan
- Narita, Ichiei, Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
Background
Secondary hyperparathyroidism (SHPT) is a major complication in hemodialysis (HD) patients. Calcimimetics have been shown to improve bone turnover by suppressing parathyroid hormone (PTH) production. However, it remains unclear whether the degree of bone turnover influences the efficacy of calcimimetics. This study aimed to evaluate the efficacy of Upacicalcet on PTH suppression and changes in bone turnover, based on baseline alkaline phosphatase levels.
Methods
A post-hoc analysis was conducted on data from a phase 3, placebo-controlled, double-blind study of Upacicalcet in HD patients with SHPT. Patients were categorized into three groups based on tertiles of baseline serum bone-specific alkaline phosphatase (BAP) concentrations. Serum concentrations of intact PTH, BAP, tartrate-resistant acid phosphatase-5b (TRACP-5b), and BAP/TRACP-5b ratio were measured. Percent change from baseline in these parameters was assessed using a mixed-effects models for repeated measures. Differences in bone turnover markers among the three BAP groups at 24 weeks were evaluated using Tukey-Kramer multiple comparison adjustment.
Results
The analysis included 103 HD patients with SHPT treated with Upacicalcet. Patients were categorized into low BAP (<12.8 μg/L), medium BAP (12.8–18.8 μg/L), and high BAP (>18.8 μg/L) groups based on baseline serum BAP concentrations. After 24 weeks intervention with Upacicalcet, intact PTH concentration decreased in all baseline BAP groups. There was a tendency for a greater decrease in PTH in the low BAP group compared to the medium (13.7±5.4%, p=0.0287) and high BAP groups (11.9±5.7%, p=0.0906). Serum concentrations of BAP and TRACP-5b decreased, while the serum BAP/TRACP-5b ratio increased in all groups.
Conclusion
Upacicalcet decreased serum intact PTH concentration regardless of the degree of bone turnover. The effect was more pronounced in patients with low BAP levels, however, Upacicalcet may improve bone turnover in HD patients with any bone metabolism state.
Funding
- Commercial Support – Sanwa Kagaku Kenkyusho co.,ltd.